Patient Medication Information: uses, side effects, how to take - Mylan-Azithromycin
What is MYLAN-AZITHROMYCIN used for?
MYLAN-AZITHROMYCIN is an antibiotic medicine used to treat the following types of mild to moderate infections by certain microorganisms in adults such as bronchitis, certain types of skin infections, strep throat (pharyngitis, tonsillitis), genitourinary infections, disseminated mycobacterium avium complex (MAC) disease in people with HIV, and pneumonia.
Antibacterial drugs like MYLAN-AZITHROMYCIN treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, MYLAN-AZITHROMYCIN should be taken exactly as directed. Misuse or overuse of MYLAN-AZITHROMYCIN could lead to the growth of bacteria that will not be killed by MYLAN-AZITHROMYCIN (resistance). This means that MYLAN-AZITHROMYCIN may not work for you in the future. Do not share your medicine.
How does MYLAN-AZITHROMYCIN work?
MYLAN-AZITHROMYCIN helps stop the growth of the bacteria that cause infection. It gets into infected tissue where it is released slowly over time so the medicine keeps fighting bacteria for many days after the last dose is taken. This is why MYLAN-AZITHROMYCIN may be taken for as short a time as one day.
What are the ingredients in MYLAN-AZITHROMYCIN?
Medicinal ingredient: Azithromycin dihydrate
Non-medicinal ingredients:
250 mg tablets: Croscarmellose sodium D&C Red No. 27, FD&C Blue No. 2, FD&C Red No. 40, FD&C Yellow No.6, Hydroxypropylmethyl Cellulose, Lactose, Magnesium Stearate, Poloxamer 188, Povidone, Silicified Microcrystalline Cellulose, Polyethylene Glycol, Talc and Titanium Dioxide.
MYLAN-AZITHROMYCIN comes in the following dosage forms:
Tablets: 250 mg.
Do not use MYLAN-AZITHROMYCIN if you:
- have a history of liver problems when you have used azithromycin.
- are hypersensitive (allergic) to azithromycin, or any macrolide or ketolide antibiotic (including erythromycin) or any other ingredient of MYLAN-AZITHROMYCIN (see What are the ingredients in MYLAN-AZITHROMYCIN).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take MYLAN-AZITHROMYCIN. Talk about any health conditions or problems you may have, including if you:
- have a known prolonged heart cycle (interval) (QT prolongation)
- are currently taking medication known to prolong QT interval (prolong your heart cycle) such as antiarrhythmics (drugs to regulate your heart beat such as class IA: quinidine, procainamide and class III; dofetilide, amiodarone, sotalol); antipsychotic agents; antidepressants; and fluoroquinolones (a class of antibiotics)
- have a history of life-threatening irregular heart beat
- have constantly low levels of potassium or magnesium in your blood
- have a history for heart problems such as slow heart rate, irregular heart beat or cardiac insufficiency (your heart has a hard time pumping blood to your body)
are pregnant or think you are pregnant,
- are breast feeding or planning to breastfeed. Azithromycin has been reported to be excreted in human breast milk. It is not known if MYLAN-AZITHROMYCIN could affect your baby. Discuss with your doctor.
- have ever had any liver or kidney problems
- have a weak immune system
have ever had an allergic reaction to any medicines,
including antibiotics such as erythromycin
- have myasthenia gravis (a chronic autoimmune neuromuscular disease which causes muscle weakness)
- have hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption as this product contains lactose.
Other warnings you should know about:
You should begin to feel better within the first few days, but be sure to take MYLAN-AZITHROMYCIN for the full number of days your doctor prescribed. Although MYLAN-AZITHROMYCIN dosing is short, you should not expect MYLAN-AZITHROMYCIN to work faster than other antibiotics which are dosed up to 10 days. If you stop taking MYLAN-AZITHROMYCIN too soon, your infection could come back. The next infection may be worse and be more difficult to treat. If you are not able to take all the medicine, tell your doctor.
If you develop diarrhea during or after treatment with MYLAN-AZITHROMYCIN, tell your doctor at once. Do not use any medicine to treat your diarrhea without first checking with your doctor.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with MYLAN-AZITHROMYCIN:
- Warfarin (or other anticoagulant medicine);
- Cyclosporin (used to suppress the immune system to prevent and treat rejection in organ or bone marrow transplants);
- Digoxin (used for treatment of heart problem);
Nelfinavir (used for treatment of HIV infections);
- Ergotamine and ergot derivatives (used for migraine treatment). Ergotamine and ergot derivatives should not be used with MYLAN-AZITHROMYCIN.
Some medicines may affect how well MYLAN-AZITHROMYCIN works. Check with your doctor before starting any new prescription or over-the-counter medicines, including natural/herbal remedies or antacids, while on MYLAN-AZITHROMYCIN.
How to take MYLAN-AZITHROMYCIN:
Always take MYLAN-AZITHROMYCIN as the doctor has prescribed for you, depending on the specific condition you have.
MYLAN-AZITHROMYCIN can be taken with or without food.
Usual adult dose:
If your doctor prescribes MYLAN-AZITHROMYCIN 250 mg tablets for 3 days for treatment of bronchitis:
Days 1 through 3: Take two tablets each day.
If your doctor prescribes the 5 day MYLAN-AZITHROMYCIN 250 mg tablets for 5 days for treatment of respiratory tract infections or certain types of skin infections:
Day 1: Take 2 tablets once.
Day 2 through 5: Take 1 tablet daily.
If your doctor prescribes MYLAN-AZITHROMYCIN 250 mg tablets for 1 day for treatment of genital ulcers or non-gonococcal urethritis and cervicitis:
Days 1:Take four tablets once.
If your doctor prescribes MYLAN-AZITHROMYCIN 250 mg tablets for 1 day for treatment of gonococcal urethritis and cervicitis:
Days 1: Take eight tablets once.
Overdose:
If you think you have taken too much MYLAN-AZITHROMYCIN, contact your healthcare professional, hospital emergency department or regional Poison Control Center immediately, even if there are no symptoms.
Missed Dose:
If you forget to take a dose, call your pharmacist or doctor. Do not double dose.
What are possible side effects from using MYLAN-AZITHROMYCIN?
These are not all the possible side effects you may feel when taking MYLAN-AZITHROMYCIN. If you experience any side effects not listed here, contact your healthcare professional.
Side effects may include:
- Diarrhea/loose stools
- Stomach pain
- Nausea and vomiting
- Headache
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
COMMON Clostridium difficile colitis (bowel inflammation): severe diarrhea (bloody or watery) with or without fever, abdominal pain, or tenderness | √ | ||
UNCOMMON Abnormal heart rhythm: feel your heart beating in your chest, abnormal heartbeat, dizziness or feeling faint | √ | ||
Severe allergic reaction: trouble breathing, swelling of the face, mouth, throat, neck, severe skin rash or blisters | √ | ||
Liver disorder: abdominal pain, nausea, vomiting, yellowing of skin and eyes, dark urine | √ | ||
Myasthenia gravis: muscle weakness, drooping eyelid, vision changes, difficulty chewing and swallowing, trouble breathing | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, talk to your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store MYLAN-AZITHROMYCIN at controlled temperature between 15°C and 30°C
Keep MYLAN-AZITHROMYCIN and all medicines out of the reach and sight of children.
If you want more information about MYLAN-AZITHROMYCIN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://health-products.canada.ca/dpd-bdpp/index-eng.jsp); the manufacturer’s website or by calling 1-844-596-9526.